Drugs
FDA has deferred a review action on GlaxoSmithKline’s PD-1 drug dostarlimab, indicated for treating endometrial cancer, because it could not conduct a manufacturing site inspection due to Covid-19 concerns. The company is telling several media outlets that while the site inspection has not occurred yet, it is
FDA Policy/General
As the transition of power concludes in Washington, DC and CDER director Janet Woodcock assumes temporary control of FDA until a new commissioner is appointed, we are reminded just how important an independent and a free-from-political-interference agency really matters. A Vanity Fair special report examines how former
Devices
FDA has cleared an Eitan Medical 510(k) for its upgraded Sapphire infusion pump system and software Rev15, which includes pump, administration sets and accessories. The device is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition, lipids, IV medication, perineural
Drugs
L.E.K. Consulting says that FDA approval for a new drug is no guarantee of commercial success. In a report on lessons learned from the company’s Launch Monitor, L.E.K. says that to drive real value, biopharma companies must execute the launch process flawlessly. “As history shows,
FDA Policy/General
Federal Register Final Rule: The Regulatory Flexibility Act (RFA) requires agencies like FDA to publish plans to conduct periodic reviews of certain of their regulations. To further comply with the RFA and subsequent executive orders, and to ensure the department’s regulations have appropriate impacts, HHS is issuing the final
Drugs
FDA has removed a partial clinical hold on a Pieris Pharmaceuticals Phase 1 study of PRS-343 that was issued while the company conducted an additional in-use and compatibility study requested by the agency. Currently-enrolled patients were permitted to continue to receive treatment, the company said, but no
Biologics
FDA commissioner Stephen Hahn and senior advisor Colin Rom say the agency has signed a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products, and medical devices through the adoption
Drugs
FDA has released the 39-page FDA-483 containing 13 detailed observations issued following a 9/10-11/5/2020 inspection at Novel Laboratories, doing business as Lupin, Somerset, NJ. The inspection observations were: * failing to clean and sanitize at appropriate intervals equipment and utensils to prevent malfunctions and contamination
Drugs
FDA has granted accelerated approval to Janssen Biotech’s Darzalex Faspro (daratumumab plus hyaluronidase) for combination use with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis. The approval was based on data from the ANDROMEDA (NCT03201965) trial in 388 patients with measurable disease and at least one affected
Drugs
FDA has approved a Daiichi Sankyo BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Approval was based on data from the DESTINY-Gastric01 (NCT03329690) trial in patients with
Devices
FDA has cleared a DePuy Synthes 510(k) for the Velys Robotic-Assisted Solution and its use with the Attune Total Knee System. The robotic device is designed to adapt to the “surgeon’s workflow, and is designed to give them the control they are used to and helps them
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Bodyhealth.com, Clearwater, FL (12/9/2020) An FDA review of the company’s Web site (www.bodyhealth.com) has determined that
Biologics
U.S. Stem Cell, Inc., Sunrise, FL, says it argued 1/13 before the 11th Circuit Court of Appeals that it should be allowed to present evidence and testimony in support of its position and practices in a trial. The case involves a 5/9/18 FDA suit against the
Biologics
FDA has accepted for priority review an Omeros BLA for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). HSCT-TMA is a significant and often lethal complication of stem cell transplantation. “This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning
Devices
FDA has given PMA approval for Seno Medical Instruments’ diagnostic breast cancer imaging technology that the company says helps doctors better differentiate between benign and malignant breast lesions. Seno says its Imagio breast imaging system uses non-invasive opto-acoustic ultrasound technology to provide real-time information on suspicious breast
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Data to Support Drug Product Communications as Used by the Food and Drug Administration,” (OMB Control Number 0910–0695). The collection supports agency outreach efforts, such as testing of communication messages in advance of a communication campaign.
FDA Policy/General
Three staff in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine of the University of Pennsylvania say FDA “cannot make decisions on the basis of science alone, and political considerations sometimes do have a role to play.” In an online letter to the editor
FDA Policy/General
In an interview less than 24 hours before he leaves office with the change in presidential administrations, FDA commissioner Stephen Hahn has acknowledged significant pressure from the White House over Covid-19 vaccines and treatments. “I heard loud and clear from the White House, President Donald Trump, and others, that
Drugs
FDA has issued an immediately-in-effect guidance, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency, to alert drug manufacturers and pharmacists who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl
FDA Policy/General
20 Drug Determinations on ANDA Availability Federal Register notice: FDA has determined that 20 drug products (detailed below) were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will continue to approve ANDAs that refer to the products as long as they meet
FDA Policy/General
Federal Register notice: FDA has rescheduled a public meeting for 2/12 on “Patient-Focused Drug Development for Vitiligo,” which was originally scheduled to occur 3/30/2020. The meeting is intended to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and
FDA Policy/General
Federal Register notice: FDA has announced a 4/7 virtual public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting is intended to fulfill an FDA user fee agreement commitment to seek stakeholder input about data standards and the electronic submission system’s